FDA recall Z-2950-2024

Mindray DS USA, Inc. dba Mindray North America · Class II · device

Product

Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00

Reason for recall

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

Distribution

US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada

Key facts

Status
Ongoing
Initiation date
2024-07-22
Report date
2024-09-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2950-2024